Two Promising PARP inhibitor Study Results-SOLO2 and OlympiAD

by Piri Welcsh, PhD

Results from two PARP inhibitor studies, one in ovarian cancer, and the other in breast cancer, hold promise for better treatment options and improved outcomes for people with cancer caused by a BRCA mutation. FORCE was part of the recruitment efforts for both of these landmark studies, and we are excited to report these positive, hopeful results.

SOLO2

Late-breaking results from the phase III SOLO2 study were presented at the Society of Gynecologic Oncologists Annual Meeting on Women’s Cancer this past week. The goal of this study was to see if olaparib (brand name, Lynparza), given as “maintenance therapy” after platinum based chemotherapy, increased progression-free survival the length of time a patient survived without cancer getting worse. The study was open to women with recurrent ovarian cancer that had responded well to chemotherapy. All patients enrolled had a known BRCA mutation.

Lynparza was approved in the United States in 2014 for the treatment of patients with inherited BRCA mutations and advanced ovarian cancer that progressed following three or more lines of chemotherapy. SOLO2 was the second study to use Lynparza as a maintenance therapy for BRCA mutation carriers with recurrent ovarian cancer.

Results from SOLO2

The results revealed that women who were given Lynparza as a maintenance therapy after chemotherapy was completed had a longer period of time until progression, compared to women who were given a placebo. For those patients who received Lynparza, progression-free survival was 30.2 months, compared to 5.5 months for those who received a placebo. However, it is important to note that the researchers stated that they do not yet know the effect of Lynparza on overall survival. Results from SOLO2 confirm the findings from an earlier maintenance study of olaparib for recurrent ovarian cancer, which led to approval of olaparib for that indication in Europe.

OlympiAD

Results from another clinical trial involving Lynparza, the Phase III OlympiAD trial, were announced last month. This trial was designed to evaluate the effectiveness and safety of Lynparza compared to a “physician’s choice” chemotherapy for 302 patients with HER2-negative metastatic breast cancer who had an inherited BRCA mutation.

Results from OlympiAD

The patients treated with Lynparza had significant improvement in progression-free survival compared with those who received “physician’s choice” chemotherapy.

OlympiAD is the largest study to show that PARP inhibitors may be better than chemotherapy for people with a BRCA mutation who have advanced breast cancer, . To date, results from the OlympiAD have only been reported in a press release. The full results will be presented at an upcoming scientific meeting.

What’s Next?

While the analysis of the OlympiAD trial is ongoing, these results are important for the FORCE community, as they could lead to FDA approval of Lynparza for metastatic breast cancer caused by an inherited BRCA mutation

When the FDA first approved Lynparza in 2014 for 4th-line treatment of advanced ovarian cancer, it mentioned waiting for the results of SOLO2 before approving Lynparza for maintenance. Hopefully, with these results the FDA will now grant approval for Lynparza in the ovarian cancer maintenance setting. Experts anticipate that the PARP inhibitor niraparib will also be approved this year by the FDA for maintenance therapy for recurrent ovarian cancer.

Both OlympiAD and SOLO involved patients with known BRCA mutations. However, it is important for members of our community who have other hereditary breast and ovarian cancer genes to note that research on PARP inhibitors continues for use in a wider group of people. Furthermore, because the spectrum of cancer in people who inherit BRCA mutations also includes prostate and pancreatic cancer as well as melanoma, other studies are looking at PARP inhibitors for these cancers as well.

As with SOLO and OlympiAD, FORCE plays a role in hereditary cancer recruitment efforts. Visit the research section of the FORCE website to find hereditary cancer treatment and preventing studies. We will continue to share the results of these studies as they are reported.

Posted 03/27/17

Help us achieve our goal of enrolling 15,000 people in HBOC Research.

The FORCE Research Advocate Training (FRAT) Program is a basic educational course aimed at preparing people to become engaged in research advocacy on behalf of the hereditary breast and ovarian cancer community.

The goal of the ABOUT network is to enroll as many Americans with HBOC risk as possible into our research registry and to collect information and real world health care experiences that can be used along with information from medical records to improve care for people with HBOC.

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